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AzTrials

Helicobacter Pylori InfectionPhase 3THD-HPNCT04107194

Non-invasive Test-guided Tailored Therapy Versus Empiric Treatment for Helicobacter Pylori Infection.

A Phase 3 study testing Pantoprazole 40mg, Amoxicillin 1000 MG and Clarithromycin 500mg in people with Helicobacter Pylori Infection and Antibiotic Resistant Infection, run by University of Bari at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of our study will be to assess in an open-label, multicenter, randomized controlled trial whether a tailored therapy guided by a non-invasive antibiotic susceptibility test on stool samples achieves higher Helicobacter eradication rates than an empiric antibiotic regimen. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Pantoprazole 40mg, Amoxicillin 1000 MG and Clarithromycin 500mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
362 participants
Where
1 siteItaly
Study dates
14 Jan 2020to 14 Apr 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • presence of dyspeptic symptoms, according to Rome IV criteria;
  • Helicobacter pylori infection diagnosis by the positivity of at least 2 out of 4 diagnostic tests (i.e. histology, rapid urease test, urea breath test, and serology);
  • naive to Helicobacter pylori treatment;
  • written informed consent.

Who cannot join

  • previous Helicobacter pylori treatment;
  • diagnosis of gastric cancer or other diseases requiring surgery;
  • contraindications to upper endoscopy;
  • chronic diarrhea;
  • known allergy to any drugs used in the intervention and control arm.

Trial locations and contacts

1 site in 1 country.

Michele Barone, Prof. contact

+39 3477157666

michele.barone@uniba.it

Italy1 site, 1 recruiting

  • Michele Barone

    Bari, BA, 70124

    Michele Barone, 3477157666, michele.barone@uniba.it

    Recruiting

Other trials in Italy

About this study

Official title: Comparison Between Tailored Therapy Guided by a Non-invasive Antibiotic Susceptibility Test and Empiric Treatment for First-line Helicobacter Pylori Eradication in Patients With Dyspepsia: a Randomized Controlled Trial.

The aim of our study will be to assess in an open-label, multicenter, randomized controlled trial whether a tailored therapy guided by a non-invasive antibiotic susceptibility test on stool samples achieves higher Helicobacter eradication rates than an empiric antibiotic regimen. For this purpose, consecutive patients with dyspeptic symptoms, diagnosis of Helicobacter pylori infection and naïve to eradicating treatments will be allocated to either of the two intervention arms.

Read the detailed description

Study design:

Eligible subjects will be defined by the positivity to at least 2 out of 4 tests for Helicobacter pylori infection diagnosis (i.e. histology, rapid urease test, urea breath test and serology). Stool samples and gastric biopsy specimens of eligible patients will be analyzed at enrollment, using real time-polymerase chain reaction (RT-PCR) to detect bacterial DNA mutations conferring resistance to amoxicillin, clarithromycin, tetracycline, metronidazole, and levofloxacin. Participants allocated to the tailored intervention arm will receive an antibiotic combination therapy according to the result of stool sample molecular analysis. Participants allocated to the empiric intervention arm will be treated by either a quadruple concomitant or bismuth-containing regimen, according to the 2017 European Helicobacter pylori management guidelines. In all participants, infection eradication will be evaluated 30 days after treatment end, using urea breath test. We will also assess the diagnostic accuracy of the RT-PCR on fecal samples in detecting bacterial antibiotic resistances, using the RT-PCR on gastric biopsy specimens as the reference standard.

Being tested
Pantoprazole 40mg, Amoxicillin 1000 MG, Clarithromycin 500mg, Metronidazole, Tetracycline 125 MG

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pantoprazole 40mgDrug

    Also called Pantorc

    Proton pump inhibitor

  • Amoxicillin 1000 MGDrug

    Also called Zimox

    Antibiotic

  • Clarithromycin 500mgDrug

    Also called Klacid

    Antibiotic

  • MetronidazoleDrug

    Also called Flagyl

    Antibiotic

  • Tetracycline 125 MGDrug

    Also called Ambramicina

    Antibiotic

  • Bismuth SubcitrateDrug

    Also called Denol

    Antibiotic adjuvant

  • Rifabutin 150 MGDrug

    Also called Mycobutin

    Antibiotic

  • Levofloxacin 500mgDrug

    Also called Levoxacin

    Antibiotic

Study groups in NCT04107194
Study groupRoleWhat they receive
Tailored therapyExperimental1. Clarithromycin-sensitive strain (10 day-therapy): Pantoprazole 40 mg bid (tablet) Amoxicillin 1000 mg bid (tablet) Clarithromycin 500 mg bid (tablet) Metronidazole 500 mg bid (tablet) 2. Clarithromycin-resistant and tetracycline-sensitive strain (10 day-therapy): Pantoprazole 40 mg bid (tablet) Tetracycline 125 mg + metronidazole 125 mg + bismuth 140 mg in a single tablet (3 tablets qid) 3. Clarithromycin- and tetracycline-resistant and levofloxacin-sensitive strain (10 day- therapy): Pantoprazole 40 mg bid (tablet) Amoxicillin 1000 mg bid (tablet) Levofloxacin 500 mg bid (tablet) 4. Clarithromycin-, tetracycline- and levofloxacin-resistant strain (10 day-therapy): Pantoprazole 40 mg bid (tablet) Amoxicillin 1000 mg bid (tablet) Rifabutin 150 mg bid (tablet)
Receives: Drug: Pantoprazole 40mg; Drug: Amoxicillin 1000 MG; Drug: Clarithromycin 500mg; Drug: Metronidazole; Drug: Tetracycline 125 MG; Drug: Bismuth Subcitrate; Drug: Rifabutin 150 MG; Drug: Levofloxacin 500mg
Empiric therapyActive comparatorEither one of the two following 10-day regimens (according to physician's decision): 1. Pantoprazole 40 mg bid (tablet) Amoxicillin 1000 mg bid (tablet) Clarithromycin 500 mg bid (tablet) Metronidazole 500 mg bid (tablet) 2. Pantoprazole 40 mg bid (tablet) Tetracycline 125 mg + metronidazole 125 mg + bismuth 140 mg in a single tablet (3 tablets qid)
Receives: Drug: Pantoprazole 40mg; Drug: Amoxicillin 1000 MG; Drug: Clarithromycin 500mg; Drug: Metronidazole; Drug: Tetracycline 125 MG; Drug: Bismuth Subcitrate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Eradication rate

    Number of participants achieving Helicobacter pylori eradication

    Measured: 30 days

Secondary outcomes (3)

  1. Adverse events

    Any adverse event occurring during the 10-day treatment

    Measured: 10 days

  2. Participants' compliance

    Number of assumed tablets divided by the total number of prescribed tablets

    Measured: 10 days

  3. Treatment withdrawal

    Withdrawal of any drug included in the prescribed regimen

    Measured: 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2019
  2. Study start14 Jan 2020
  3. Primary completion14 Feb 2021 (estimated)
  4. Study completion14 Apr 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Open-label, multicenter, parallel-arm randomized controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
362 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04107194
Sponsor's protocol ID
Policlinic Hospital 6, Bari
Acronym
THD-HP
Status last verified
Jan 2021
First submitted
25 Sep 2019
Last updated
12 Jan 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Malfertheiner P, Megraud F, O'Morain CA, Gisbert JP, Kuipers EJ, Axon AT, Bazzoli F, Gasbarrini A, Atherton J, Graham DY, Hunt R, Moayyedi P, Rokkas T, Rugge M, Selgrad M, Suerbaum S, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study Group and Consensus panel. Management of Helicobacter pylori infection-the Maastricht V/Florence Consensus Report. Gut. 2017 Jan;66(1):6-30. doi: 10.1136/gutjnl-2016-312288. Epub 2016 Oct 5.

    PubMed 27707777

  • Iannone A, Giorgio F, Russo F, Riezzo G, Girardi B, Pricci M, Palmer SC, Barone M, Principi M, Strippoli GF, Di Leo A, Ierardi E. New fecal test for non-invasive Helicobacter pylori detection: A diagnostic accuracy study. World J Gastroenterol. 2018 Jul 21;24(27):3021-3029. doi: 10.3748/wjg.v24.i27.3021.

    PubMed 30038469

  • Giorgio F, Ierardi E, Sorrentino C, Principi M, Barone M, Losurdo G, Iannone A, Giangaspero A, Monno R, Di Leo A. Helicobacter pylori DNA isolation in the stool: an essential pre-requisite for bacterial noninvasive molecular analysis. Scand J Gastroenterol. 2016 Dec;51(12):1429-1432. doi: 10.1080/00365521.2016.1216592. Epub 2016 Aug 9.

    PubMed 27687850

  • Drossman DA. Functional Gastrointestinal Disorders: History, Pathophysiology, Clinical Features and Rome IV. Gastroenterology. 2016 Feb 19:S0016-5085(16)00223-7. doi: 10.1053/j.gastro.2016.02.032. Online ahead of print.

    PubMed 27144617

  • De Francesco V, Giorgio F, Hassan C, Manes G, Vannella L, Panella C, Ierardi E, Zullo A. Worldwide H. pylori antibiotic resistance: a systematic review. J Gastrointestin Liver Dis. 2010 Dec;19(4):409-14.

    PubMed 21188333

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pantoprazole 40mg, Amoxicillin 1000 MG and Clarithromycin 500mg in people with Helicobacter Pylori Infection and Antibiotic Resistant Infection, run by University of Bari at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Michele Barone, Prof. (+39 3477157666, michele.barone@uniba.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Eradication rate (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04107194, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2021.

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